Supplement manufacturing requires a lot of intricate procedures. From raw material testing and monitoring the production process to comprehensive finished product testing, quality control is crucial to ensure that products are safe and effective. Contract supplement producers must steadfastly adhere to all essential laws and standards. This ensures that the supplements are safe, secure, and efficient.
Inspecting Raw Materials
The dietary supplement manufacturing industry is vast and largely unregulated. Supplements can be made from many different natural ingredients, and it can be challenging to distinguish which products are high quality. The quality of the raw materials that go into a supplement is crucial. Subparity in the manufacturing process can lead to product recalls, regulatory action, and a loss of consumer trust in your brand. Review the dietary supplement firm’s written procedures to review and approve incoming ingredients and components, including identity testing and verification of supplier information.
Inspect a sampling of these materials, the incoming receipts, and the finished dietary supplements to ensure compliance with CGMP. Evaluate the dietary supplement firm’s controls for sanitation, maintenance and pest control, and storage facilities. Inspect the sanitizing, cleaning, and labeling a sampled batch of finished dietary supplements. Inspect the encapsulation suites and verify a swab test is performed on each capsule barrel contents before production.
Inspecting the Process
Once the raw materials are tested and approved, it’s time for the production procedure to begin. This quality control stage includes various activities, including contaminant testing, label and packaging accuracy checks, stability testing (to ensure that the supplements won’t lose their potency over time), and much more. Every process step must be inspected by trained QC staff to verify that it meets regulatory standards. Some companies make it a point to adhere to strict quality control procedures, which helps them create safe and efficient supplements that meet all the necessary regulations. A lack of these procedures can result in fines, product recalls, and a loss of consumer trust. This can be avoided by working with a contract manufacturer with a proven track record of adhering to all the appropriate laws and guidelines.
Testing the Finished Product
Once the production procedure is completed, the final product should undergo a series of tests to ensure it meets all the specifications. This includes contaminant testing, label and packaging accuracy, and stability testing to ensure the product won’t lose potency over time. The production and process control procedures should be designed to ensure that the dietary supplements have the identity, strength, quality, and purity they are represented to possess. These include the receipt, inspection, identification, storage, and handling of raw materials and in-process dietary supplement ingredients. Last year, four of the ten firms that the FDA cited for violating manufacturing rules failed to establish or adequately set specification limits for the finished batch’s identity, strength, and composition. To minimize the chance of similar incidents, contract manufacturers should be Informed Manufacturer certified to demonstrate that they have high-level systems to prevent banned substance contamination within their facilities.
Inspecting the Packaging
The dietary supplement packaging must contain sufficient information to ensure the product is safe and effective. This includes warning statements, usage directions, and storage suggestions. The packaging must also be tamper-resistant. Some dietary supplement brands use special labeling to meet this requirement, while others integrate tamper-evident features into their packaging design. A quality control unit should be established for approving or rejecting any procedures or specifications that impact the finished dietary supplement’s identity, strength, quality, or purity. This unit should have adequate laboratory facilities for testing and be capable of reviewing production records. Supplement brands looking to improve their manufacturing processes and quality control should consider implementing the Informed Manufacturer program to reduce the risk of banned substance contamination within sports nutrition and dietary supplement facilities. Additionally, they can work with a supplier that offers eco-friendly plastic packaging solutions compliant with the APR Design Guide for Plastics Recyclability.